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Friday, December 18, 2009

NNVC NanoViricides Presentation Summary

CEO Seymour's 12/11/2009 presentation in .mp3 format, annotated.

Background. On Dec. 11, Dr. Eugene Seymour MD, MPH gave a presentation at the Equities Magazine Conference about NanoViricides. This article is a collection of what I think is the best information about this presentation. If you have more information, please post it in the comments section after this article.

From "No Attribution Requested"

I took the liberty of accessing the audio file of Dr. Seymour's December 11th, 2009 presentation to the Equities Magazine Conference that "leifsmith" so handily acquired and posted, and converted it from ".m4u" format to the more universally readable ".mp3" format. I also went through the presentation and pulled out and referenced what I consider to be some of it's most significant points.

The presentation runs 38:17, and has been uploaded to some server space that I rent:

While most of the material covered in the presentation is already known to those of us who closely follow the company, there are a few points that I don't think have been previously publicly disclosed (at least I'd never heard them before):

* The CDC has had initial success in it's testing of Rabicide, and additional tests are currently underway.

* The company intends to apply for uplisting off of the Bulletin Board exchange in the near future.

* The company is beginning a Hepititus C study soon.

* The prototype production facility has been physically built, and will begin production shortly. Guessing this is at TheraCour, with the money having been generated from the TheraCour limited share sales over the past year.

* Animal studies are already underway which hope to show whether NanoViricides has a "full cure" for HIV, not just a "functional cure" as has previously been reported.

* The "hint" that NanoViricides might believe they stand a good chance of getting a government grant relative to development of drugs for tropical viral diseases of Ebola, Marburg, and Dengue.

This is all pretty exciting stuff! Thanks to "leifsmith" for doing the work of obtaining the presentation audio!

Best to all.

Time-Referenced Annotation of Significant Points:

5:50 [Rabies and Ebola] "We've had very good success with a drug against Rabies, both in Vietnam and at the Centers for Disease Control [CDC], and we're currently working on the Ebola virus at the U.S. Army Medical Research Institute for Infectious Diseases [USAMRIID]"

12:00 [NanoViricides drug pipeline in development and in testing: Influenza-A, External viral diseases of the eye including Herpes and Adenovirus, HIV AIDS, Dengue, Rabies, Ebola, Marburg, and ability to rapidly create new drug in the field in response to novel infection or viral bioterrorist attack].

20:05 "Our plan is now to apply to a national exchange [i.e. uplist off of Bulletin Board]."

20:15 [Potential markets for Nanoviricides drugs] HIV $21B opportunity over next few years, and possibly much higher. Influenza [no figure given], viral eye drops $1B to $5B, Hepatitis C -- there are 175 million people infected with Hepatitis C. Mention of Dengue, Ebola and Marburg with no figures given.

21:45 [Plans for 2010] "We are applying to a national exchange, whether it will be NASDAQ or AMEX I'm not sure at this time." "We're working on an agreement for initiation of research coverage, we have no research coverage currently." "A new [web site] will be coming next month [i.e. January 2010]". "We've applied for a number of federal grants and I can't really talk about what the status of those grants are but you can see that the government is very interested in what we're doing and are doing a number of studies with our material in their [the government's] own laboratories."

22:40 [More Plans for 2010] "We're going to announce the results of various animal studies, a repeat of HIV, Ebola from the Army, and Marburg . . . and then Herpes Simplex infections of the skin and genitals, we have a study starting on cold sores, Dengue will be starting next month [i.e. January 2010], Rabies is underway [presumably at the CDC], Hepititus C starts at the beginning of the year [2010], Adenovirus / Herpes virus of the eye." "We have a lot of things in progress, and we've done this on a minimal amount of money. I think we've spent ten million dollars over four and a half years, and have nine drugs in various stages of [pre-clinical] animal trials."

23:30 [Toxicology Studies in Animals and Humans] "The important thing is [to] complete the first set of animal toxicity studies. We've already done 2000 animals [and] we've had no evidence of toxicity. We anticipate none in humans because the nanomicelle is made of a polymer that's been used in humans for years and it's non-toxic and biodegradable. We [our drugs] do not go into cells, we are not metabolized by the liver, because once we break down the virus this is just excreted by the kidneys. And then we have to set up our first meeting with the FDA."

24:05 [New Laboratory / Production Facility] "We have completed the physical space of a new 6,000 sq. ft. plant, and we're going to start our prototype manufacturing at the beginning of the year [presumably this is a TheraCour facility that was financed by recent TheraCour limited share sales as reported in numerous SEC Form 4 filings over the past year]."

25:30 [Audience Question -- Competitors and Human FDA Trial Length]

Q: "How large are our competitors?"A: "We don't know anybody who's doing the same work we're doing in viruses using nanomedicine materials. There's a tremendous amount of work going on with cancer and nanomedicine . . . the problem with developing drugs for cancer is the clinical [FDA] trials run 5, 7, 8, 10 years, [while] a clinical trial for influenza could run a week, two weeks, you come to New York or the east coast during a flu epidemic and you can pick up all the cases you need, you treat half you don't treat [the other] half and you see who does what."

26:55 [HIV "Functional Cure"] "We have reported [previously] that we've achieved a 'functional cure' [for HIV] in the animal model, which is used as the model for all HIV drugs -- 'functional cure' means we've eradicated any evidence of the [HIV] virus in the circulation, essentially the people are now no longer contagious. The next step to go to a 'full cure' is to be able to eradicate the virus that's hidden inside what's know as the CD4 Lymphocytes, hidden within the lymph nodes, and that is now being tested during one of our studies."

27:30 [Regarding competition from other drug developers] "I'm not really concerned about competition, the [combined] market [for all of our target viral diseases] is well over $40B dollars."

27:40 [Audience Question -- Human FDA Trial Length]

Q: "You haven't done any human studies yet . . . you have to go through Phase I, II, and III, and that takes about ten years before anything's out on the market"

A: "It would take ten years if it were a cancer drug, but we can do the studies that we need to do for influenza in an extraordinarily short time because it's an acutely limited disease because it's an active infection. So, what you can do is combine the [FDA] Phase I [and] Phase II studies. . . . and then you go into an expanded Phase III trial. The estimates given to me by people in the industry is that we're looking at [potentially] no more than three years [to complete the full FDA approval process] but this is totally up to the FDA."

29:50 [Audience Question -- Timing of First IND]

Q: "What do you think will be the timing of your first successful IND and when do you think you would commercialize your first compound?"

A: "The idea is for our first meetings with the FDA to be next year [2010]. We're starting on the toxicity studies; I'm getting quotes right now. So, it depends on how fast they [the tox studies] go."

30:25 [Manufacturing Process] "I also have an agreement with a private pharma company who would be our manufacturing partners since we don't intend to manufacture . . . the way this is done it looks like a brewery . . . we estimate that four vats [12' tall by 8' in diameter] will make 150 million doses of whatever [NanoViricides drug] per year. . . if you want to make 3 billion doses you have 20 times as many clusters of vats. This is not a complex chemical type of manufacturing process. It's really adding various polymers into the mix and the nanomicelle self-assembles.

34:00 [Audience Question -- Funding]

Q: "Hopefully next year you are going to be beginning the process of moving into [FDA] clinical trials. That's very exciting it's also very expensive. What is your financial strategy moving forward?"

A: "Number one, partnering with a large phama. Our goal is to license each one of these drugs to a different pharma company in a partnership arrangement. Number two, the government is very interested in, for example with Ebola and Marburg, to take these through the FDA and get these approved because they're very concerned about this being a potential weaponized virus. I can't talk yet because I'm not really allowed to talk about it but let's just say that I have no interest in taking Ebola through the system personally and unless someone else pays for it, and we wouldn't do it, and you know who that 'someone else' is -- it's not a pharma company."

36:30 [Clarification on Drug Development and Pre-Clinical Trial Process] "We build the drugs, we design them using the computer, and we give you at the Army of you at Feinstein [Institute for Medical Research], you take the drug, we work on the protocol with you, you do the study and you report it to us, and then if modifications have to be made we modify it and give it back to you."

A: "I think we had [in recent SEC filings] $4.2M dollars [cash], something like 18 months of cash. We burn about $200k to $250k a month. Obviously we're going to need more money. I'm looking for non-dilutive ways to get that money. The way to do it is through government grants or through partnerships with pharma companies. The problem with partnerships with the pharma companies is they want to take 85% of the sales revenue, on the other hand, if you have something that has value in the billions of dollars, then 15% of that number is not bad. For Gilead [pharma company] for example, they do $6B dollars in revenue from their AIDS drugs. Now, what if a product comes along that changes the game, makes it possible to eradicate the [HIV] virus, and their [existing] business goes away, you can imagine they'd be very interested in an acquisition."

/end

From Kirk on Friday, December 18, In reply to: "No Attribution Requested"Do you mind if I repost this elsewhere to spread the news of NNVC? Let me know how you want me to attribute this great work to you.Thanks.

From "No Attribution Requested" on Friday, December 18, 2009To: Kirk

The 'great work' was the presentation by Dr. Seymour.Please feel free to copy, repost, edit, append, or otherwise change or use the text of my "presentation post", and the link to the .mp3 file, in any way that you feel serves the interests of the company and the shareholders. No attribution to me is needed, and I would prefer none.best to you.

Disclosure: I own NNVC in my personal and newsletter accounts with shares recently purchased at 56¢ and 46¢ for overall profits in my position as of this writing. I have targets to take profits on these shares listed in the newsletter should my price objective be reached. I will not announce buying or selling ahead of time here on the blog.NNVCUSD NANOVIRICIDES INC

There is some confusion over what you said would be the time frame for IND, Phase 1, 2 and 3 Human trials. Could you elaborate on your discussion regarding combining trials such as Phase 1 and 2.

1. How close is the company regarding filing a first IND? What steps remain?2. How many patients can we expect to be involved in each trail whether done separately or together?3. What might be the expected length of those trials, and how long might it be between trials?

* Additionally, which of the indications do you see emerging first into Human trials? If you are reluctant to answer, then which are more likely to reach that status?* Finally, when you referred to having a manufacturer lined up, were you talking about the "big pharma" with which you have the MTA agreement? Or, is this a separate arrangement?

We on the iHUB NNVC board, which I understand you do follow on occasion, are grateful for any of the above questions you can shed light upon. However, please feel free to only answer those questions that you are able answer at this time.

Unfortunately, I never heard the webcast but only saw comments about it

#1) Occasionally, companies are given permission to combine Phase I and Phase II. This decision by the FDA is usually predicated on either the toxicology or the pre-clincal studies being done in animals that closely resemble humans (primates) or for the eye, rabbits.

#2) Plans for IND filing is predicated upon our ability to provide material produced in a GMP facility so rather than rushing into the FDA, it's smarter to gather as much pre-clinical animal data as possible while GMP production is underway. This gives a Company additional time to fill in any holes in the submission package in order to facilitate the movement through the FDA. We have recently completed construction on the 6000 sq ft prototype production facility and are now in the process of buying equipment necessary to not only produce but to analyze the output of the production equipment. Once we are satisfied that the production process can be dramatically scaled up, we will give the production parameters to our production partner. I feel that the eventual partner will be the private contract pharma manufacturer who had agreed to be our production partner for purposes of the large federal grant that we applied for at the beginning of the year.

#3) Generally, Phase I safety studies require 10-20 healthy volunteers to take the drug. I am intimately familiar with this process since, like many of my classmates, worked my way through medical school as a professional guinea pig. Following Phase I, one applies to the FDA for permission to move into Phase II studies which are efficacy. The patient numbers vary but I would hope we would be able to limit the numbers to 200 or so. These are sick people. For people with the flu, one can obtain the necessary number very quickly during a flu outbreak. The medical director of one of the CRO's (clinical research organizations) feels that he could get all of the necessary people over a weekend. The study would then last 1-2 weeks since the natural history of the disease is rather short. I suspect the Phase II trials would be longer for HIV and Hep C. Phase III is then totally up to the FDA. If the results in the Phase II trials are dramatic, the patient numbers could be lower in Phase III but it's really the FDA's call. Also, even though the trial with data collection could go quickly, putting the data into a form that would be acceptable to the FDA as well as doing all of the statistical analyses can take some time. Since all of the target diseases are infectious and are self-limited (except HIV and Hep C) data can be collected rather quickly. This is unlike a trial for a cancer drug where you're comparing the effectiveness against a five year survival standard. Those trials run into years and years. This won't be the case with our drugs since all of the diseases are generally self-limited (except HIV and Hep C)

#4) I can't say which of our drugs will go into the FDA first. The eye drug makes a lot of sense since it's topical as are the skin and genital herpes drugs. On the other hand, if the government is willing to pay for Ebola/Marburg to go through trials, they may be a reasonable candidate to go first because there are no human trials, just animals.

#5) The "mystery pharma" is a public company and the production pharma is a private contract manufacturer that has contracts with a number of public pharmas to produce their drugs. The private pharma bought a large pharma's manufacturing facility and are using it to service a number of large companies

#6) I wish I could be more specific as to the time between Phases and the length of the overall studies but it's a big unknown at present. I would imagine that a drug for dengue (since one doesn't currently exist), would move readily through the system. Also, since there is very little dengue (AT PRESENT) in the US (Puerto Rico has a nasty problem), it's also possible to go to countries where the disease is a problem and get it approved there. I've been approached by a group in Russia that's interested in moving the HIV drug through the system in Russia. That's a backdoor way of expediting the US approval process because the AIDS advocacy people in the US would put pressure on the FDA if the drug turns out to be better than the existing treatment options. I've also been approached by a CRO in Basel, Switzerland who feel they can get the eye drug approved 1/3 faster there. I have to research the effects of approval in a developed country vis a vis the US FDA. Fortunately, people within our Company have taken 12 drugs to market. In addition, one of our scientific advisory board members is an FDA consultant so plan to draw on their expertise.